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St. Jude recall

This article was originally published in The Gray Sheet

Executive Summary

Firm recalls more than 5,000 of its 6-French Engage introducers used to implant catheters and electrodes into blood vessels during surgery while helping to prevent bleeding. The firm announced the action after learning that the device shaft may separate from the hub or the hub assembly may break, causing potentially life-threatening bleeding. The affected devices were produced between April 27 and June 3, 2010. St. Jude alerted customers in a June 24 letter. FDA placed the recall in the highest-risk Class I category

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